ASX Announcements, Company News 28 Apr 2025 Orthocell Receives Regulatory Approval to Commence Sales of Remplir™ in US$84 million Thai market Orthocell has been granted a licence by the Food and Drug Administration of Thailand to commence sales of Remplir™ into… Orthocell
ASX Announcements, Company News 24 Apr 2025 Orthocell Appoints its First Four US Remplir™ Distributors Orthocell has appointed four US distributors for its flagship nerve repair product Remplir™, enabling the commencement of commercial distribution into… Orthocell
ASX Announcements, Company News 04 Apr 2025 US FDA grants 510(k) clearance for Orthocell’s flagship Remplir™ nerve repair product Orthocell has announced that the US Food and Drug Administration has granted regulatory clearance under the 510(k) pathway for the… Orthocell
ASX Announcements, Company News 21 Feb 2025 Thailand Regulatory Application for Remplir™ Orthocell has submitted a regulatory application to the FDA of Thailand to commence sales of its groundbreaking nerve repair device… Orthocell
ASX Announcements, Company News 03 Feb 2025 Orthocell Submits Canada Regulatory Application to Commence Sales of Remplir™ into US$75million Canadian market Orthocell has announced it has submitted an application to Health Canada for a Medical Device Licence (MDL) to sell its… Orthocell
ASX Announcements, Company News 19 Dec 2024 Orthocell Submits U.S. FDA Regulatory Application Orthocell has announced the submission of its U.S. FDA 510(k) regulatory application for clearance to commercially distribute Remplir™ into the… Orthocell
ASX Announcements, Company News 12 Dec 2024 Orthocell Achieves Major Milestone with First Sales of Remplir™ in Singapore Orthocell has today announced the achievement of first sales of Remplir™ in Singapore, marking another significant milestone in its global… Orthocell
ASX Announcements, Company News, Evidence 02 Dec 2024 Orthocell successfully completes US FDA 510(k) regulatory study for Remplir™ Orthocell has today reached another significant milestone with the successful completion of its Remplir™ 510(k) nerve repair regulatory study, validating… Orthocell
ASX Announcements, Company News 27 Nov 2024 Orthocell Appoints Exclusive Distributor to Commence Sales of Remplir™ in Singapore Orthocell has announced that it has appointed Device Technologies Asia as the exclusive distributor of market leading peripheral nerve repair… Orthocell
ASX Announcements, Company News 11 Nov 2024 Appointment of Key US Executives to Lead Remplir™ Launch Orthocell has appointed two experienced US-based executives to drive the market launch and sales of Remplir™ following the expected US… Orthocell
